Method of Sampling Systemic Biomarkers

ABSTRACT

A method including a step of preparing a sampling apparatus for use. The sampling apparatus includes a tubular member having an opening on a distal end thereof. An orientation of the distal end of the tubular member is shapeable. The distal end is substantially rigid so as to maintain a manipulated shape after a direct application of a threshold level of force on the distal end of the tubular member. The tubular member also includes a joint member disposed on a proximal end of the tubular member. The joint member is configured to connect the tubular member to a systemic biomarker sampling device.

RELATED APPLICATIONS

This application claims priority to and is a continuation of U.S. patentapplication Ser. No. 14/726,322, filed on May 29, 2015, the entirecontents of which are incorporated herein by reference.

BACKGROUND

In dental procedures during which either sedation or General Anesthesia(GA) is required, a patient may wear a nasal mask or hood via which agas, such as oxygen or nitrous oxide, is administered to the patient.The nasal mask or hood may be a non-latex, soft, thermal plasticelastomer that covers the nose and is secured to the face via agravitational pull of a bilateral inspiratory and gas scavenging suctionsystem that hangs from around the patient's head and over the nose whilein the recumbent position. Alternatively, other methods of sedation areaccomplished without a nasal hood, such as a combination of nasalcannula for oxygen with oral, intramuscular, or submucosal modes ofanesthetic delivery. During procedures that deliver anesthetics, it isimportant that the patient's airway and the delivery of gases aremonitored closely because, in some instances, the effects of sedatives,narcotics, and the majority of general anesthetics decrease respiratorydrive and can cause brief or prolonged periods of apnea.

It is well documented and widely accepted that the implementation ofcapnography increases the margin of safety for delivery of anesthesia.Capnography is the monitoring of the concentration of end tidal carbondioxide (“ETCO₂”) or exhaled carbon dioxide (“CO₂”) of a patient inorder to assess the physiological status and/or determine the adequacyof ventilation when under anesthesia. Nevertheless, due to the currentlyexisting difficulties associated with monitoring ETCO₂, particularlywithin dentistry due to the tools and work occurring in the mouth of thepatient, practitioners do not commonly monitor ETCO₂.

In addition to monitoring ETCO₂, operators may be further interested inaccurately sampling for and/or detecting the levels of other systemicbiomarkers found within exhaled breath of a person under sedation or GAin order to assess a patient's status. Therefore, a means to accuratelydetect and monitor systemic biomarkers, such as ETCO₂, within exhaledbreath is desirable.

BRIEF DESCRIPTION OF THE DRAWINGS

The Detailed Description is set forth with reference to the accompanyingfigures. In the figures, the left-most digit(s) of a reference numberidentifies the figure in which the reference number first appears. Theuse of the same reference numbers in different figures indicates similaror identical items. Furthermore, the drawings may be considered asproviding an approximate depiction of the relative sizes of theindividual components within individual figures. However, the drawingsare not to scale, and the relative sizes of the individual components,both within individual figures and between the different figures, mayvary from what is depicted. In particular, some of the figures maydepict components as a certain size or shape, while other figures maydepict the same components on a larger scale or differently shaped forthe sake of clarity.

FIG. 1A illustrates a side view of an example of an exhaled breathsampling apparatus.

FIG. 1B illustrates a front cross-sectional view at line I-I of thetubular member of the example exhaled breath sampling apparatus in FIG.1A.

FIG. 1C illustrates a side view of another example of an exhaled breathsampling apparatus.

FIG. 1D illustrates a front cross-sectional view at line II-II of thetubular member of the example exhaled breath sampling apparatus in FIG.1D.

FIG. 2A illustrates a side view of another example of an exhaled breathsampling apparatus.

FIG. 2B illustrates a side view of another example of an exhaled breathsampling apparatus.

FIG. 2C illustrates a side view of another example of an exhaled breathsampling apparatus.

FIG. 2D illustrates a side view of another example of an exhaled breathsampling apparatus.

FIG. 3A illustrates an exploded, side view of an example of a proximalend of a tubular member of an exhaled breath sampling apparatus.

FIG. 3B illustrates an exploded, partial-cross-sectional side view ofanother example of a proximal end of a tubular member of an exhaledbreath sampling apparatus.

FIG. 3C illustrates an exploded, partial-cross-sectional side view ofanother example of a proximal end of a tubular member of an exhaledbreath sampling apparatus.

FIG. 3D illustrates an exploded, side view of another example of aproximal end of a tubular member of an exhaled breath samplingapparatus.

FIG. 3E illustrates an exploded, side view of yet another example of aproximal end of a tubular member of an exhaled breath samplingapparatus.

FIG. 4A illustrates an exploded, side view of an example of a distal endof a tubular member of an exhaled breath sampling apparatus.

FIG. 4B illustrates an exploded, partial-cross-sectional side view ofanother example of a distal end of a tubular member of an exhaled breathsampling apparatus.

FIG. 4C illustrates an exploded, partial-cross-sectional side view ofanother example of a distal end of a tubular member of an exhaled breathsampling apparatus.

FIG. 4D illustrates an exploded, partial-cross-sectional side view ofanother example of a distal end of a tubular member of an exhaled breathsampling apparatus.

FIG. 4E illustrates an exploded, partial-cross-sectional side view ofanother example of a distal end of a tubular member of an exhaled breathsampling apparatus.

FIG. 5 illustrates a partial-cross-sectional side view of anotherexample of an exhaled breath sampling apparatus.

FIG. 6A illustrates an example of a modified connector used in anexisting nasal hood so as to permit connection of an exhaled breathsampling apparatus.

FIG. 6B illustrates the connector component of FIG. 6A.

FIG. 7 illustrates an alternative example of an exhaled breath samplingapparatus connected to an existing nasal mask.

FIG. 8 illustrates a perspective view of an alternative example of anexhaled breath sampling apparatus.

FIG. 9A illustrates a perspective view of an alternative example of anexhaled breath sampling apparatus paired with an existing dentalproduct.

FIG. 9B illustrates a top cross-sectional view of the alternativeexample of the exhaled breath sampling apparatus in FIG. 9A.

FIG. 9C illustrates a perspective view of an alternative example of anexhaled breath sampling apparatus paired with an existing dentalproduct.

FIG. 9D illustrates a top cross-sectional view of the alternativeexample of the exhaled breath sampling apparatus in FIG. 9C.

FIG. 10 illustrates an example of a method of monitoring systemicbiomarkers according to the instant application.

DETAILED DESCRIPTION Overview

This disclosure is directed to a method and apparatus that may be usedin monitoring the presence of and/or concentration of a systemicbiomarker, such as ETCO₂ or exhaled CO₂, in the exhaled breath of apatient, in order to assess the physiological status and/or determinethe adequacy of ventilation during a procedure that may involve sedationor GA. The embodiments are described with specificity in order to meetstatutory requirements. However, the description itself is not intendedto limit the scope of this patent. Rather, the inventors havecontemplated that the claimed invention might also be embodied in otherways, to include different elements or combinations of elements similarto the ones described in this document, in conjunction with otherpresent or future technologies.

The sampling apparatus described herein may be structured to be insertedinto a patient's mouth and/or connect to another device to sampleexhaled breath from a patient's nose and/or mouth. Accordingly, thesampling apparatus may include a tubular member (also called “a samplingline”) and a connector attached to the tubular member. The tubularmember permits the flow of exhaled breath to go from the patient to amonitoring device, where a systemic biomarker, such as ETCO₂ exhaled bythe patient, is monitored for the safety of the patient. Systemicbiomarkers may include, for example, ETCO₂, nitric oxide, moisture,humidity, temperature, acids, ketones, or other gases, elements, orcharacteristics found in or associated with exhaled human breath. Abiomarker that may be particularly useful is CO₂, since the averageindoor CO₂ levels range from 400-2000 ppm, whereas exhaled CO₂ levelsrange around 38,000 ppm.

The tubular member may be manufactured such that at least a portionthereof is manipulable and has plastic material properties so as to bedeformable continuously and permanently in any direction withoutrupture. This manipulable feature provides the operator of theapparatus, e.g., the anesthesiologist, dentist, or other medicalpersonnel, the ability to alter the shape and orientation of theapparatus to better position apparatus where it may more consistentlymonitor the systemic biomarker, such as ETCO₂.

Other advantages of the sampling apparatus relate to its versatilityincluding, but not limited to, being connectable to or integral with, anasal mask, a nasal hood, an oral airway, and a dental Isolite® system.Furthermore, in embodiments described below, the sampling apparatussamples exhaled air from both the nose and mouth. An additionaladvantage is that in embodiments, a length of the sampling apparatus maybe quickly and easily adjustable to accommodate the different sizes ofpatients.

Various embodiments allow for different means of connection between thecomponents of the sampling apparatus itself, between the samplingapparatus and the systemic biomarker sampling device, and the samplingapparatus and the procedural apparatus with which the sampling apparatusmay be coupled.

Sometimes, using the current methods of practice monitoring ETCO₂ duringa procedure, issues and problems related to reliability, and potentiallydangerous situations occur. Moreover, patients may even alternatebreathing through the nose and the mouth. In such an instance, a nasalsampling line alone will not reliably sample and/or detect exhaled aircoming from the mouth. The sampling apparatus of the instant applicationhelps to eliminate or minimize the occurrence of such situations.Namely, the sampling apparatus helps to avoid kinking or occlusions ofthe sampling line (which may be crafted from, for example, intravenouscatheter or extension tubing). Further, the sampling apparatus mayeliminate the situation where sampling line is taped to the patient'sfacial skin. In some instances, hypodermic needles are broken duringcurrent procedures and used to puncture the nasal mask so as to inserttubing therein and sample the CO₂. In such situations, the patient maybe subject to a possible cut or abrasion from the broken end of theneedle. Accordingly, the embodiments of the sampling apparatus of theinstant application, as detailed herein, may provide several advantagesover the current methods of monitoring CO₂.

Multiple embodiments of an apparatus that may be used to achieve thedesired effects of the instant application, including the ability toreliably sample and detect a systemic biomarker, such as CO₂, aredescribed herein below with respect to FIGS. 1A-9B. Note, throughout thespecification the terms “proximal” and “distal” appear several times.Unless otherwise specified, “proximal” refers to the side of thesampling apparatus closer to the end that connects to the systemicbiomarker sampling device 150 (FIGS. 1A and 1C), such as an ETCO₂monitor, and “distal” refers to the side of the apparatus closer to theopposite end of the sampling apparatus which receives the exhaled breathfrom the patient.

First and Second Illustrative Embodiments

Inasmuch as the features of FIGS. 1A and 1C are substantially similar,the components of each figure are herein below discussed simultaneously,with the exception of any specific feature that is unique to either oneof the figures. Accordingly, substantially similar components aredescribed as, for example, “connector 102A, 102C,” which indicates thatthe connector on each of the figures may be generically described,insofar as they are similar unless explicitly stated otherwise.

Thus, FIGS. 1A-1D illustrate an example sampling apparatus 100A, 100Cthat may include a tubular member 102A, 102C having a plurality ofopenings 105 (fenestrations) on the distal end, via which exhaled breathmay be sampled from a patient. It is noted that for the sake ofsimplicity in the drawings, only FIGS. 1A and 1C show an embodimentincluding a plurality of openings 105 in the distal end of the device.Nevertheless, it is contemplated that any of the embodiments shown ordiscussed in this application may include either a single opening ormore than one opening. Although it may be possible to use a device ofthe instant application that only has one opening 105, there may beadvantages to having a plurality of openings 105, which may not beachievable with a single opening.

The tubular member 102A, 102C may be a piece of tubing, for example, ofmedical grade tubing. A connector 104A, 104C may be attached to aproximal end of the tubular member 102A, 102C. The connector 104A, 104Cmay connect to an extension tube (not shown) leading to a systemicbiomarker sampling device 150, or may directly connect to the samplingdevice. The means of connection implemented by the connector 104A, 104Cmay vary according to user preference, method of manufacture, or commonconnections available such as a Luer-Lok® type of connection, forexample. See some additional examples of types of connections consideredin FIGS. 3A-4E. When in use, a pump or other means may create a suctionforce through the tubular member 102A, 102C to sample the patient'sbreath through the tubular member 102A, 102C at the sampling device,whereby the sampling device may monitor a level of a biomarker, such asETCO₂, within the breath.

Additionally, the apparatus 100A, 100C may include a cap 106A, 106Chaving one or more corresponding openings therethrough and may bedisposed to align with the one or more openings 105 on the distal end ofthe tubular member 102A, 102C. The cap 106C, as shown in FIG. 1C, mayhave a soft, gradual, rounded edge on the distal end thereof, and may betapered in the longitudinal direction thereof such that thecross-sectional area of the proximal end of the cap 106C is larger thanthe cross-sectional area of the distal end of the cap 106C. The taperedand rounded features of cap 106C may serve multiple purposes, including,but not limited to comfort of the patient on which the apparatus is usedand convenience of the operator, respectively. For example, the soft,rounded edges on the distal end of the cap may prevent harm or annoyanceto a patient when placed in a patient's mouth or near the patient'sface, when compared with a tube having a rough edge. Further, asdiscussed in greater detail below, the tapered shape may act as aconnector in embodiments, as it creates a wider proximal area on the capthan the distal area of the cap. The wider surface area surrounding thetubular member may act as a backstopping surface to prevent accidentalremoval of the tubular member (described in greater detail herein belowwith respect to FIG. 7). Alternatively, the tubular member 102A, 102Cmay not have a cap, and instead the distal end of the tubular member maybe shaped in a tapered manner itself or may be left as originallymanufactured (not shown). In the case where no cap is used, the risk ofhaving the cap come off and enter the patient's body is eliminated.

In the embodiments shown in FIGS. 1A and 1C, the respective distal endsthereof are bent such that the distal end is oriented transversely to amain direction of extension of the majority of the tubular member 102A,102C. Note, however, the tubular members 102A, 102C may be temporarilypre-shaped during manufacturing to be straight or to include a curved orhooked shape, for example, which may ease the placement of the tubularmember 102A, 102C within a patient's mouth at the time of use in amanner that is out of the way of the work being done in the patient'smouth.

Additionally and/or alternatively, the tubular member 102A, 102C mayinclude a manipulable characteristic or component, so that a least aportion of the tubular member 102A, 102C is shapeable and yetsubstantially rigid so as to maintain a manipulated shape upon a directapplication of a threshold level of force on the portion of the tubularmember 102A, 102C. The threshold force, which may be applied by anoperator to alter the shape of the portion of the tubular member 102A,102C, is that force sufficient to overcome the inherent resistance forcefrom a property of rigidity associated with the chosen material that isused to manufacture the manipulable characteristic of the tubular member102A, 102C. The term “substantially rigid” is intended to convey themeaning that, while the orientation of the tubular member 102A, 102C maybe altered under a deliberate act of a threshold force by an operator,the rigidity of the tubular member 102A, 102C is such that it is not solimp or flimsy as to bend and flex into a different orientation underthe mere presence of a gravitational force, for example, when lifted orshifted from a resting state.

As an example of the manipulable characteristic or component, in FIG.1A, the material of the tubular member 102A may have properties suchthat a shape of the tubular member 102A itself is manipulable due to thematerial forming the tubular member 102A. Materials that may be used forthe manipulable material may include, for example, ductile or malleablemetals such as aluminum, pliable plastics, rubber, and some ceramics, ora combination thereof.

In an alternative example embodiment, instead of, or in addition to, thematerial of the tubular member itself being manipulable, a distinctmanipulable member 108 may be molded, manufactured, embedded, inserted,or otherwise attached to either an inside or an outside of the wall ofthe tubular member 102C, or disposed within the wall of the tubularmember 102C, as shown in FIG. 1C. For example, the manipulable member108 may be disposed in the wall of the tubular member 102C adjacentlumen 110. Similar to having a manipulable material, as described withrespect to FIG. 1A, the manipulable member 108 enables the operator toadjust the size, shape, position, and/or direction of extension of atleast the distal end of the tubular member 102C, so as to be able toplace the tubular member 102C within, on, or around the mouth of apatient.

In embodiments, the manipulable member 108 may include a wire, rod,strip, bar, or another section of metal, plastic, ceramic, rubber, orother suitable material. The material of the manipulable member 108 maybe such that the manipulable member 108 is pliable and, when theapparatus 100C is used to sample and/or detect a biomarker during aprocedure, the manipulable member 108 may be manipulated to form acurved distal end, such as a quarter round, or a hook shape, if theoperator desires. Additionally, the length of the manipulable member 108may be such that the manipulable member 108 extends:

-   -   1) throughout the entire length of the tubular member 102C;    -   2) at least along the distal end of the tubular member 102C (see        for example FIGS. 2A-2D; or    -   3) for a portion less than the entire length of the tubular        member 102C and located away from the ends thereof, such as at a        middle portion between the distal and proximal ends (not shown).

An advantage of the manipulable member 108 in the distal end of thetubular member 102A, 102C is that the operator may place the samplingapparatus 100A, 100C between a patient's teeth and cheek so that themouth cavity is free of obstructions during the procedure. Thusly, thedistal end of the tubular member 102A, 102C is positioned to suction thepatient's breath and monitor a predetermined biomarker in the breath viathe intake into lumen 110.

Inasmuch as the manipulable member 108 is adjacent the first lumen 110,the manipulable member 108 may be disposed in a second lumen in the wallof lumen 110 so as to extend parallel with lumen 110, as shown moreclearly in FIG. 1D. As indicated above, alternatively, the manipulablemember 108 may be attached directly to an inner surface of the lumen 110or an outer surface of the tubular member 102C; or the manipulablemember 108 may simply be embedded in the wall of the lumen 110, as itappears in FIG. 1D.

In comparison, FIG. 1B shows a cross-sectional view of the tubularmember 102A in FIG. 1A as a solitary lumen having a substantiallyuniform wall thickness, whereas FIG. 1D shows a cross-sectional view oftubular member 102C with lumen 110 as a first lumen, or a solitarylumen, and manipulable member 108 embedded in the wall or inserted intoa second lumen large enough to secure the manipulable member 108.

Third-Sixth Illustrative Embodiments

In FIGS. 2A-2D, various alternative embodiments of the samplingapparatus 200A-200D are shown. Inasmuch as several of the features foundin the various embodiments of FIGS. 2A-2D are similar with respect toeach other, as well as with respect to some features in FIGS. 1A-1D, thesimilar features are described briefly together. Features in individualFIGS. 2A-2D that are unique to the respective embodiment or distinctfrom other depicted embodiments, however, may be described explicitlyand separately below for clarity.

Generally, each apparatus (200A-200D) may include:

-   -   a first tubular member (202A-202D),    -   a joint member (204A-204D),    -   a cap (206A-206D),    -   a manipulable member (208A-208D),    -   a second tubular member (210A-210D),    -   a connector (212A-212D),    -   a sampling return line (214A-214D),    -   length measurement indicator marks (shown on FIGS. 2D, 3A, and        3B-4E).

First Tubular Member

Inasmuch as the first tubular members 202A-202D shown in FIGS. 2A-2D maybe similar to the tubular members 102A, 102C in FIGS. 1A, 1C, thedetails of the first tubular members 202A-202D are not reiterated againhere. It is noted, however, that in order to accommodate different sizesof patients, the first tubular members 202A-202D may be detachable fromthe respective joint members 204A-204D to be able to adjust the lengththereof. The adjustability of the tubular members is discussed ingreater detail herein below.

Joint Member

In embodiments, a sampling apparatus may include a joint member 204A, asshown in FIG. 2A, which has a T-shape. Specifically, the first tubularmember 202A extends from one side arm of the T-shape joint member 204A,and the second tubular member 210A extends from the other opposing sidearm of the T-shape joint member 204A so as to extend collinearly withthe first tubular member 202A. The sampling return line 214A, therefore,extends from the stem portion of the T-shaped joint member 204A, whichis transverse to the arms of the T-shape.

In embodiments, a sampling apparatus may include a joint member 204B, asshown in FIG. 2B, where the joint member 204B may have a tubular shapeso as to connect the first tubular member 202B collinearly with thesampling return line 214B. The joint member 204B may further include ahole in which the second tubular member 210B is adjoined, whereby thesuction on the sampling return line 214B draws exhaled breath from boththe first and second tubular members 202B and 210B.

In other embodiments, a sampling apparatus may include a joint member204C, as shown in FIG. 2C, where the joint member 204C may be a jointthat is formed at the time of manufacture, as an integral, Y-shapedunion of the first and second tubular members 202C and 210C and thesampling return line 214C. In other words, the joint member 204C may notbe a separate component, to which ends of the first and second tubularmembers 202C and 210C and the sampling return line 214C are secured, asis depicted in FIGS. 2A and 2B. Rather, instead, the merging of thefirst and second tubular members 202C and 210C and the sampling returnline 214C may be a single component formed either entirely together oras a composite united at the time of manufacture.

Further still, in other embodiments, such as the embodiment shown inFIG. 2D, the joint member 204D is a Y-shaped component into which theends of the first and second tubular members 202D and 210D and thesampling return line 214D are secured to one of the three branches ofthe Y-shaped joint member 204D.

Cap

Inasmuch as the features of the cap 206A-206D shown in FIGS. 2A-2D maybe similar to the cap 106A, 106C in FIGS. 1A, 1C as depicted, thedetails of the cap 206A-206D are not reiterated again here. It is noted,however, that when a cap is implemented, the risk of harm to a patientmay be reduced when the cap is completely affixed to the tubular memberso that there is little or no chance of the cap coming off into thepatient during use. For example, the cap could be glued on or otherwiseformed to be permanently attached to the tubular member. Alternatively,as previously indicated, a cap may not always be implemented in everyembodiment.

Manipulable Member

Manipulable members 208A-208D may be disposed, respectively, within thefirst tubular members 202A-202D, in a manner similar to that shown inFIG. 1C, and as described above. Thus, the details of the manipulablemembers 208A-208D are not reiterated again here. Note, while themanipulable members 208A-208D are depicted as not extending throughoutthe entire length of the respective tubular members 202A-202D andtherefore differ from the manipulable member 108 shown in FIG. 1C, it iscontemplated that within the depicted embodiments, the manipulablemembers 208A-208D may, alternatively, extend throughout an entirety ofthe respective tubular members 202A-202D.

Furthermore, although explicitly depicted as a distinct element for thesake of clarity, the manipulable members 208A-208D may be integralelements of the first tubular members, for example, as the actualmaterial of the tubular members.

Additionally, in FIG. 2D, the apparatus 200D may also include a secondmanipulable member 218D, having characteristics like those of the firstmanipulable member 208D. As such, the details of the second manipulablemember 218D are not reiterated here again. It is noted, however, thatthe ability to adjust the manipulable member 218D facilitatespositioning the second tubular member 210D in a particular location, forexample in a nasal mask as described with respect to FIG. 7, as may benecessary during use.

Second Tubular Member

Additionally, each of the apparatuses 200A-200D, respectively, mayinclude a second tubular member 210A-210D, which may be coupled to therespective first tubular member 202A-202D via the respective jointmember 204A-204D. In practice, the first tubular members 202A-202D maybe used to sample breath exhaled via the patient's mouth, and the secondtubular members 210A-210D may be used to sample breath exhaled via thepatient's nose. Specific examples of how the first and second tubularmembers sample breath from mouth and nose, respectively, is discussedherein below with respect to FIGS. 6A-7.

Connector

In the embodiments depicted in FIGS. 2A, 2B, and 2C, the respectivesecond tubular members 210A-210C may have disposed at the distal endsthereof connectors 212A-212C, respectively, which may be similar to theconnectors 104A, 104C in FIGS. 1A, 1C. Since the second tubular members210A-210C may sample the exhaled breath from a patient's nose, theconnectors 212A-212C may be configured to connect to a correspondingconnection piece on a nasal mask or hood (see FIGS. 6A and 6B discussedherein below). Further, inasmuch as the connectors 212A-212C areillustrated simply a generic box, it is contemplated that the connectors212A-212C may be of any suitable type to form a secure connection to thenasal mask or hood, including the manners of connection described hereinbelow with respect to the joint members/caps in FIGS. 3A-4E. Forexample, the connectors 212A-212C may be threaded, possibly like aLuer-Lok® connection, or may be structured to form a compression fit, aninterference fit, a friction fit, or any other connection that permits agas flow.

In the embodiment depicted in FIG. 2D, the connector 212D may appearsimilar to caps 206A-206D, however, connector 212D may function as theconnection point between the apparatus 200D and a nasal mask like theone shown in FIG. 7, and therefore, is considered a connector.

Sampling Return Line

FIGS. 2A-2D also depict a sampling return line 214A-214D. The samplingreturn line 214A-214D may extend from the respective joint member204A-204D to a systemic biomarker monitor device (not shown). Moreover,the suction that draws exhaled breath from the first tubular member202A-202D to the monitor device may also draw exhaled breath from thesecond tubular member 210A-210D by way of the joint member 204A-204D,which joins the first and second tubular members to the respectivesampling return line 214A-214D. Thusly, exhaled breath may be sampleddirectly from a patient's mouth and nose in order to provide a moreaccurate assessment of the vital statistics of a patient underanesthesia.

Length Measurement Indicator Marks

Although not illustrated on the embodiments of FIGS. 2A-2C, the lengthmeasurement indicator marks 220D shown on each of the first and secondtubular members 202D and 210D may be incorporated on any of theembodiments of FIGS. 2A-2C, as well. Length measurement indicator marks220D are shown as disposed along a portion of the length of the firstand second tubular members 202D and 210D. In view of the different sizesand shapes of people who may need to undergo a procedure in which theapparatus of the instant application may be used, length measurementindicator marks 220D provide a guideline for an operator to be ableadjust the length of either one or both of the first and second tubularmembers 202D and 210D, depending on the measured or estimated size ofthe mouth and distance to nasal mask of the specific patient. Forexample, it is possible that the original manufactured size of theapparatus may be too long for the size of the patient's mouth. In thissituation, if longer first and second tubular members 202D and 210D areused, the extended length may cause the tubular members to get in theway of the operator during the procedure. Accordingly, the operator maydesire to shorten the length of the first tubular member (if using anapparatus like the embodiments of FIGS. 2A-2C, for example), or one orboth of the first tubular member 202D and the second tubular member 210D(if using the embodiment of apparatus 200D), to minimize any amount ofexcess tubing around the patient's face.

The length measurement indicator marks 220D may be marked in incrementsof millimeters, centimeters, decimeters, inches, or any other unit oflength measurement. Further, the length measurement indicator marks 220Dmay be marked only on portion of the tubular members 202D, 210D, asshown in FIG. 2D, or along an entire length thereof. Alternatively, thelength measurement indicator marks 220D may be disposed, for example,along either the proximal end the tubular members 202D, 210D (as shown)or the distal end the tubular members 202D, 210D, or both. Thus, anoperator may measure the interior length of the distance from the backof a patient's mouth on the cheek side to the front of the patient'smouth, for example, and may shorten the total length of the apparatus200D accordingly. Depending on the embodiment used for the apparatus,shortening the length of the tubular member(s) may be accomplished bymany ways, including cutting, bending, breaking, snapping, sliding, etc.

In order to minimize the excess tubing, the following steps may befollowed. A side of the patient's cheek or the length along thepatient's teeth in the mouth may be measured. The first tubular member202D from the connector 204D. Then, using the length measurementindicator marks 220D, the operator may shorten the first tubular member202D to adjust the length thereof for the smaller size patient. Byshortening the first tubular member 202D, the operator may be able toavoid having excess tubing potentially getting in the way of the workbeing done on the patient. With regard to the second tubular member210D, since the second tubular member 210D may be inserted into a holein a nasal mask, for example, like the one shown in FIG. 7, the operatormay measure the distance between the joint member 204D and the hole inthe nasal mask on the patient's face. Then, the operator may similarlyshorten the second tubular member 210D, if necessary to accommodate asmaller distance as well.

Illustrative Embodiments of Connections at Joint Members and Caps

Due to the potential need to shorten the tubular members of theapparatus depending on the size of the patient, a manner of easily,effectively, and safely disconnecting and reconnecting the tubularmembers to either or both of the connectors and caps may be desirable.Inasmuch as a removable cap may pose a health risk to the patient, itmay be preferable to not have the cap be removable. However, it iscontemplated that the cap may be fixable such that, after adjusting alength of the tubular members, the cap may be replaced and fixed to thetubular member via a fastening means such as adhesive, means shown inthe figures, or other means so as to ensure that the cap does notinadvertently get inside the patient.

FIGS. 3A-3E depict different embodiments of potential connection typesthat may be used to connect proximal ends of a tubular member(302A-302E) to a connector (304A-304E) of an apparatus (300A-300E) ofthe instant application. Notably, FIGS. 4A-4E are placed adjacent to therespective FIGS. 3A-3E to depict corresponding connection types betweenthe distal ends of a tubular member (402A-402E) and a cap (404A-404E).Therefore, the descriptions of the connections between the joint members304A-304E and the tubular members 302A-302E, and the connections betweenthe tubular member 402A-402E and the cap 404A-404E may be substantiallysimilar and are therefore discussed together.

For the sake of simplicity and clarity in the drawings, of theembodiments in FIGS. 3A-4E, only the embodiment in FIG. 4A is actuallydepicted with the tubular member 402A having a manipulable member 406A.Regardless, it is understood that one or both ends of the tubularmembers illustrated in FIGS. 3A-3E and 4B-4E may incorporate amanipulable member. Additionally, it is noted that in an embodimentwhere a tubular member of an apparatus may be removable from both thejoint member on the proximal end and the cap on the distal end, the typeof connections used to join the adjacent parts may be different fromeach other and need not be the same type.

Specifically, FIGS. 3A and 4A depict an exploded view of a generictubular member 302A, 402A aligned with a generic joint member 304A andcap 404A, respectively. In FIG. 3A, the tubular member 302A has thereonlength measurement indicator marks 306A, while (as mentioned above),FIG. 4A depicts a manipulable member 406A. Additionally, the jointmember 304A and cap 404A each are labeled with a reference to an opening308A and 408A, respectively.

For convenience, a list of corresponding reference numbers with respectto the common components is provided here. Namely, FIGS. 3B-3E and 4B-4Einclude a tubular member 302B-302E, 402B-402E, which have thereon lengthmeasurement indicator marks 306B-306E, 406B-406E. FIGS. 3B-3E furtherinclude a joint member 304B-304E on the proximal end of the tubularmember 302B-302E, respectively, and the joint member 304B-304E isdepicted as having attached thereto a secondary tubular member312B-312E, which may serve as a nasal sampling tubular member. Alsodepicted in FIGS. 3B-3E and 4B-4E is a connection component 310B-310Eand 410B-410E, respectively. The connection components 310B-310E,410B-410E are discussed in more detail below, however, inasmuch as themanner of connection depicted between the joint members 304B-304E andthe respective tubular members 302B-302E is substantially the same asthat between the tubular members 402B-402E and respective caps404B-404E, the connection components 310B-310E, 410B-410E are explainedonce for simplicity with respect to the components as they arereferenced in FIGS. 3B-3E. Any significant differences between theconnections formed by the connection components 310B-310E and theconnection components 410B-410E are explained accordingly.

In an embodiment according to FIG. 3B, the connection component 310B mayinclude a flange extending radially, inwardly from an inside wall edgeof the distal end of the joint member 304B. Likewise, in FIG. 4B theconnection component 410B may include a flange extending radially,inwardly from an inside wall edge of the proximal end of the cap 404B.At least a portion of the length of the outer surface of the tubularmember 302B may be shaped to have a side profile that appears like aseries of alternating annular ridges and valleys (or a wave-shapedformation, ribs, etc.). In order to maintain the tubular member 302Bsecurely within the respective joint member 304B, the diameter D_(1a) ofthe opening 308B is less than a diameter D_(2a) of the “ridges,” andgreater than, or approximately equal to, the diameter D_(2b) of the“valleys.” Moreover, the diameter D_(1b) of the interior of the jointmember 304B behind the flange (connection component 310B) is greaterthan the diameter D_(1a) of the opening 308B, so as to accommodate theridges of the tubular member 302B. Furthermore, a thickness (or width)of the flange 310B approximates the length of the valleys, which is thedistance between ridges, so that the flange securely holds the tubularmember 302B. The connection formed by connection component 410B As such,when an end of the tubular member 302B, 402B is inserted into the jointmember 304B or cap 404B, the tubular member 302B, 402B flexes slightlyso that the ridges push past the flange of the connection component310B, 410B, and the flange surrounds a valley held in between tworidges, thereby securing the tubular member 302B, 402B. Additionally,the operator may use the length measurement indicator marks 306B todetermine how much of the tubular member 302B, 402B may be shortened, ifneeded.

In FIGS. 3C and 4C, a compression fit is illustrated as the connectioncomponent 310C, 410C. In particular, the diameter D₃ of the interior ofthe joint member 304C may be less than the outer diameter D₄ of thetubular member 302C. As such, when an end of the tubular member 302C ispressed into the joint member 304C, the tubular member 302C may besecured by compression in the joint member 304C. Further, connectioncomponent 310C may also include a tapered edge 310C1 at the entry to thejoint member 304C, so as to ease the insertion process between thetubular member 302C and the joint member 304C. The embodiment of theconnection component 410C with tapered edge 410C1 between tubular member402C and cap 404C of FIG. 4C may connect similarly as is depicted anddescribed above with respect to FIG. 3C.

In FIGS. 3D and 4D, an interference fit is implemented as the manner ofconnection between the tubular members 302D, 402D and the respectivejoint member 304D and cap 404D. Interference may be created between atleast one or more (as a series) of the connection components 310D, 410Dand the interior wall of the tubular member 302D and the cap 304D,respectively. Note, that while the connection components 310D aredepicted in FIG. 3D as disposed on an exterior side of the joint member304D, the connection components 410D are depicted in FIG. 4D as disposedon an exterior side of the tubular member 402D, having measurementindicator marks disposed therebetween. Regardless, the connectioncomponents 310D, 410D function similarly. In particular, connectioncomponent 310D may include one or more annular, frustoconical-shapedflanges on an exterior surface of the distal end of the joint member304D. An outer diameter of the frustoconical-shaped flange(s)(connection component 310D) may be larger than the outer diameter D₅ ofthe joint member 304D and smaller than the diameter D₆ of outer surfaceof the tubular member 302D, such that, when the tubular member 302D ispressed against the joint member 304D, the frustoconical-shaped flanges310D interfere with the inner wall of the tubular member 302D, flexingagainst the wall so as to secure the tubular member 302D to the jointmember 304D. The embodiment of the connection component 410D betweentubular member 402D and cap 404D of FIG. 4D may connect similarly as isdepicted and described above with respect to FIG. 3D. Moreover, the cap404D may include a tapered edge at the opening 408D to ease insertion ofthe frustoconical flange(s) 410D.

In example embodiments, as pictured in FIGS. 3E and 4E, the connectioncomponents 310E, 410E may include a threaded surface to make aconnection between the tubular member 302E, 402E and the respectivejoint member 304E and cap 404E. For example, in the embodiment of FIG.3E, the distal end of the joint member 304E may have a threaded surface,with the diameter D₇ of the threads on the joint member 304E beinglarger than the inner diameter of the tubular member 302E and smallerthan the diameter D₈ of the outer surface of the tubular member 302E.While the interior surface of the tubular member 302E may be threaded toassist in securing the joint member 304E, it need not be threaded, asthe threads 310E may be sufficiently sharp and rigid to bite into thematerial of the tubular member 302E when the tubular member 302E isrotated over the joint member 304E. Alternatively, as shown in FIG. 4E,instead of having threads on the outer surface of the connectingelement, the inner surface of the cap 404E is threaded. The smallestdiameter of the threaded surface may be smaller than the outer diameterof the distal end of the tubular member 402E, so that the threads insidethe cap 404E bite into the outer surface of the tubular member 402E whenthe cap 404E is rotated about the tubular member 402E, thereby securingthe cap 404E to the tubular member 402E.

Accordingly, as depicted in FIGS. 3E and 4E, a joint member and/or a capmay have internal or external threads, whereby the tubular member may besecured after sizing.

Illustrative Alternative Embodiment of an Adjustable Sampling Apparatus

FIG. 5 depicts a partial cross-sectional view of an alternativeembodiment of an adjustable sampling apparatus 500 that may include afirst tubular member 502 having a distinct proximal portion 502A and adistinct distal portion 502B. The partial cross-section is of the end ofthe proximal portion 502A so as to clearly depict the slidable aspect ofthis embodiment.

The proximal portion 502A may extend from the joint member 504. Thedistal portion 502B may be slidably insertable within the proximalportion 502A. A cap 506 may be attached to the distal portion 502B, anda manipulable element 508 may be an integral part of, disposed on, ordisposed within the distal portion 502B. (The manipulable element 508 isonly depicted as a visible “component” within the distal portion 502B asa representation of the ability to manipulate the distal portion 502B,and is not intended to exclude an embodiment of the material of thetubular member itself being the manipulable element 508.) As in otherembodiments, a second tubular member 510 may be attached to the jointmember 504, and the second tubular member 510 may have attached theretoa connector 512. The connector 512 may connect to a nasal hood or mask(not shown). Further, the sampling return line 514 may connect to thejoint member 504, as well. The first tubular member 502 may also havethereon length measurement indicator marks 516, which are used tovisualize the amount of adjustment of the length of the apparatus 500.

With regard to the manner of adjusting the length of the embodiment ofFIG. 5, FIG. 5 depicts a first sliding component 518 and a secondsliding component 520. The first sliding component 518 may include aflange extending radially, inwardly from an inside wall edge of theproximal portion 502A of the first tubular member 502. The secondsliding component 520 may include a flange extending radially, outwardlyfrom an outside wall edge of the distal portion 502B of the firsttubular member 502. A desired length position between the proximalportion 502A and the distal portion 502B may be maintained by africtional interference force between the inner wall surface of theproximal portion 502A and the outer peripheral surface of the flange ofthe second sliding component 520 on the distal portion 502B.

Inasmuch as the distal portion 502B may be slidable within the proximalportion 502A, a distal surface of the flange of the second slidingcomponent 520 opposes the proximal surface of the first slidingcomponent 518, such that the first and second sliding components 518,520, respectively are in abutment with each other in a fully extendedposition so as to prevent removal of the distal portion 502B entirelyfrom the proximal portion 502A. Further, the second sliding component520 is free to slide from the position of abutment in a direction towardthe proximal side of the apparatus 500 so as to shorten a length of theapparatus 500. Sliding may be achieved by pressing or pulling theproximal portion 502A and distal portion 502B with respect to eachother, where the pressing or pulling force is a level of force greaterthan the level of frictional force between the inner wall surface of theproximal portion 502A and the outer peripheral surface of the flange ofthe second sliding component 520. Additionally, in view of the abilityto slide the distal portion 502B within the proximal portion 502A, amaterial of at least the proximal portion 502A may be transparent ortranslucent so as to permit an operator to view the interior of theproximal portion 502A and see the end of the distal portion 502B withinthe proximal portion 502A against the length measurement indicator marks516, thereby facilitating a length adjustment.

Illustrative Example of an Embodiment of a Sampling Apparatus inConnection with a Nasal Hood

An example of a nasal hood to which the sampling apparatus of theinstant application may be coupled is the Porter Double Mask ScavengerBreathing Circuit (“nasal hood”) marketed by Porter Instrument Divisionof Parker Hannifin. FIG. 6A depicts the nasal hood 600 that may includea modified connector 602 a, a standard connector 602 b, and a nose port604. As depicted, the nasal hood 600 may further include a line-in 600 avia which gas may be administered to a patient through the nose port 604when in position over a patient's nose, and a line-out 600 b via whichexhaled breath from a patient's nose may be suctioned out. (See thearrows indicating flow in and out of the nasal hood 600 on the modifiedconnector 602 a.)

Also depicted in FIG. 6A is a portion of an example sampling apparatus606, which may connect to the modified connector 602 a to sample theexhaled breath from the patient's nose as the breath passes from theline-out 600 b through the modified connector 602 a (explained in moredetail with respect to FIG. 6B). The exhaled breath may be sampled viathe sampling return line that leads to a systemic biomarker samplingdevice 650. Note that the depicted embodiment of the example samplingapparatus 606 may resemble the embodiment illustrated in FIG. 2C, (i.e.,the integral Y-shaped joint member 204C with connector 212C resemble theportion of the example sampling apparatus 606). Any such resemblance iscoincidental and it is contemplated that any of the aforementionedembodiments of sampling apparatuses may couple with the modifiedconnector 602 a, including, for example, the embodiments of FIGS. 1A,1C, and 2A-2D. If the embodiment of FIG. 1A or 1C is coupled to themodified connector 602 a, it is contemplated that the line out 600 b maybe connected also to a systemic biomarker sampling device (such asdevice 650) in order to sample exhaled breath from the mouth and nose.Furthermore, while the modified connector 602 a is illustrated with athreaded port (discussed further with respect to FIG. 6B) thatcorresponds to the threaded connector (for example, a LuerLok®connector) on the example sampling apparatus 606, it is contemplatedthat the port may be modified to securely engage a cap such as theconnector 212D in the embodiment of FIG. 2D.

The modified connector 602 a is illustrated in more detail in FIG. 6B.In particular, the modified connector 602 a may include a line-in tube608 and a line-out tube 610, which adjoin the line-in 600 a and theline-out 600 b on nasal hood 600, respectively. A coupler 612 holds theline-in tube 608 and the line-out tube 610 together in a fixed position.At a base of the coupler 612, a sample joint tube 614 extends throughthe coupler 612 to the line-out tube 610. The end of the sample jointtube 614 includes a threaded exterior surface 616 in order to connectthe example sampling apparatus 606. As noted above, however, the samplejoint tube 614 may be configured with a secure connection means otherthan a threaded surface. That is, the coupler 612 and the line-out tube610 each have a co-aligned hole 618 in which the sample joint tube 614is disposed so as to form an additional passageway out of the line-outtube 610 for sampling the breath (note the dashed-arrow line passingfrom the line-out 610 to the sample joint tube 614.

Thus, with the Porter Double Mask Scavenger Breathing Circuit, anoperator may replace the standard connector 602 b with a modifiedconnector 602 a according to this application, and thereby connect asampling apparatus. The modified connector 602 a provides an operatorwith the ability to sample the systemic biomarkers in the exhaled breathfrom both the nose and the mouth simultaneously.

Illustrative Example of an Embodiment of a Sampling Apparatus inConnection with a Nasal Mask

Another example of a nasal mask to which the sampling apparatus of theinstant application may be coupled is the Safe Sedate® 700 (“nasalmask”) depicted in FIG. 7. In embodiments, the nasal mask 700 mayinclude a nose port 702, which has one or more exhaust holes 704. Asillustrated, the nasal mask 700 may be strapped to a patient's face sothat the mouth is clearly accessible. FIG. 7 further depicts an exampleof a sampling apparatus 200D (FIG. 2D) being connected to the nasal mask700. In particular, the sampling apparatus 200D may include a firsttubular member 202D and a second tubular member 210D, and the samplingapparatus 200D may draw exhaled breath to a systemic biomarker samplingdevice (such as device 750). The first tubular member 202D may bemanipulated to have a shape and size so that the first tubular member202D is inserted out of the way in the patient's mouth. Specifically,the first tubular member 202D may form a hook shape such that the distalend thereof may be placed around the back of the teeth in the patient'smouth, and the proximal end may extend along a side of the teeth next tothe cheek. Further, the second tubular member 210D may be sized andpositioned so as to be able to insert the connector (“cap”) on thedistal end of the second tubular member 210D into an exhaust hole 704 ofthe nasal mask 700. As stated above with respect to the cap in FIGS. 1Aand 1C, the cross-sectional area of the proximal end of the cap may belarger than the cross-sectional area of the distal end of the cap.Further, the cross-sectional area (i.e., diameter) of the exhaust hole704 may be smaller than the cross-sectional area of the distal end ofthe cap. Inasmuch as the material of the nasal mask and/or the materialof the cap has elastic properties, an operator may force the cap on thedistal end of the second tubular member 210D through the exhaust hole704. Due to the flexing of the material under force, once the proximalside of the cap has squeezed through the narrow area of the hole 704,the material is released from force and resumes its original shape.Thus, after inserting the cap through the exhaust hole, the widersurface area of the cap surrounding the tubular member may act as abackstopping surface against an inside surface of the nasal mask nearthe edge of the hole 704, and may prevent accidental removal of thetubular member.

Thus, the embodiment of sampling apparatus 200D in FIG. 2D iswell-suited for connection to the Safe Sedate® nasal mask 700. However,it is contemplated that nasal mask 700 may be modified to include adifferent means of connection, such as a threaded port, to accommodate adifferent embodiment of the sampling apparatus.

Illustrative Example of an Embodiment of a Sampling Apparatus inConnection with an Oral Airway

In yet another embodiment of how a sampling apparatus may be coupledwith a product to sample a patient's exhaled breath, FIG. 8 shows anoral airway 800 having a tube portion 802 (that sits in the patient'smouth) modified with a threaded end 804. The threaded end 804 may beconfigured to connect to a sampling apparatus 806 via a connector 808,which may be similar to a Luer-Lok® connection, for example, or may beany other type of connection between the sampling apparatus and the oralairway 800. Thus, the oral airway 800 may be inserted into a patient'smouth, and the exhaled breath may be sampled in a systemic biomarkersampling device (such as device 850) via the sampling apparatus 806.

Illustrative Example of an Embodiment of a Sampling Apparatus inConnection with an Isolite System

In yet another manner of how a sampling apparatus may be coupled with aproduct to sample a patient's exhaled breath, FIGS. 9A and 9B depict aperspective view and a top view of an Isolite® system 900 (“system”)that has been modified to accommodate the addition of an examplesampling apparatus 100A, 100C, as depicted in FIGS. 1A, 1C.Alternatively, FIGS. 9C and 9D illustrate integrated embodiments, asdiscussed in detail below.

Using an integral bite block 902 for the patient to bite down onto withone side of the patient's teeth, the system 900 is a device used indental practice to provide light and/or suction to a patient's mouthduring a procedure. In FIGS. 9A and 9B, the system 900 is depicted asmodified to include a hole 904 through the bite block 902. The tubularmember of the example sampling apparatus 100A, 100C is disposed throughthe hole 904 so that the distal end of the tubular member may be locatedbehind the system 900 in the back of the patient's mouth when the system900 is in place in a patient's mouth. Accordingly, the samplingapparatus 100A, 100C is out of the way of the dental work.

It is noted that the hole 904 was placed in the bite block 902 forconvenience and simplicity in the drawings, as well as convenient andsimple placement in manufacturing. However, it is contemplated that thehole 904 may be placed through or within any other portion of the systemso as to quickly, conveniently, and safely sample systemic biometrics atsampling device 950. For example, the system 900 may include a samplingline that is embedded within a portion of the main body of the system900, as shown in FIGS. 9C and 9D.

In the embodiment shown in FIGS. 9C and 9D, the system 910 may have asampling return line 912 extending from a portion of the bite block 902in a position such that the sampling return line 912 extends throughhole 904 into a rib 914 in the main body of the system 910. The rib 914may include holes 916 (fenestrations) through the surface of the system910, spread along the length of the rib 914 so as to be able to samplebreath from the patient.

Illustrative Method of Preparing to Sample a Patient's Exhaled BreathDuring a Procedure

In embodiments of the instant application, the steps as shown in FIG. 10may be performed as a method 1000 to prepare to sample a patient'sexhaled breath during a procedure. Step 1002 indicates that the operatormay prepare the sampling apparatus for use. Specifically, and in noparticular order, the preparation in step 1002 may further include astep 1004 of connecting the sampling return line of the samplingapparatus to the systemic biomarker sampling device. In step 1006, theoperator may couple the sampling apparatus to a procedural device. Instep 1008, the shape of the sampling apparatus may be adjusted toaccommodate the size of the patient, and likewise, in step 1010, thelength of the sampling apparatus may also be adjusted. Steps 1008 and1010 may further include measuring the patient and accordingly adjustingthe sampling apparatus, which may include one or more of bending,cutting, breaking, snapping, sliding, or otherwise adjusting the lengthor shape of the tubular member(s). When the sampling apparatus is ready,the operator may perform step 1012 of placing the sampling apparatus onthe patient. Step 1012 may further include a step 1014 of positioningthe sampling apparatus in the patient's mouth. Further, if applicable,the operator may also perform step 1016 which is to attach the samplingapparatus to a nasal mask or hood.

CONCLUSION

Although several embodiments have been described in language specific tostructural features and/or methodological acts, it is to be understoodthat the claims are not necessarily limited to the specific features oracts described. Rather, the specific features and acts are disclosed asillustrative forms of implementing the claimed subject matter.

What is claimed is:
 1. A method, comprising the following steps:preparing a sampling apparatus for use on a patient, the samplingapparatus including a tubular member having an opening on a distal endthereof, an orientation of the distal end of the tubular member beingshapeable, the distal end being substantially rigid so as to maintain amanipulated shape after a direct application of a threshold level offorce on the portion of the distal end of the tubular member, and ajoint member disposed on a proximal end of the tubular member, the jointmember being configured to connect the tubular member to a systemicbiomarker sampling device; and placing the sampling apparatus withrespect to the patient so as to sample exhaled breath from the patient.2. The method according to claim 1, wherein the step of placing thesampling apparatus includes placing the tubular member within apatient's mouth.
 3. The method according to claim 1, wherein thesampling apparatus further includes a return line, and wherein the stepof preparing the sampling apparatus includes connecting the return lineof the sampling apparatus to a systemic biomarker sampling device. 4.The method according to claim 3, wherein the systemic biomarker samplingdevice monitors ETCO₂ levels.
 5. The method according to claim 1,wherein the step of preparing the sampling apparatus includes couplingthe sampling apparatus to a procedural device configured to be disposedon a patient's nose.
 6. The method according to claim 5, wherein theprocedural device includes a path via which gas flows to the patient'snose.
 7. The method according to claim 1, wherein the step of preparingthe sampling apparatus includes adjusting a shape of the samplingapparatus to accommodate a size of the patient.
 8. The method accordingto claim 1, wherein the step of preparing the sampling apparatusincludes adjusting a length of the sampling apparatus to accommodate asize of the patient.
 9. The method according to claim 1, wherein thestep of placing the sampling apparatus includes attaching the samplingapparatus to a nasal mask or a nasal hood.
 10. The method according toclaim 1, wherein the tubular member is a first tubular member, andwherein the sampling apparatus further comprises a second tubular memberattached to the first tubular member via the joint member so as to be influid communication therewith
 11. The method according to claim 10,wherein the step of placing the sampling apparatus includes placing thefirst tubular member in a patient's mouth.
 12. The method according toclaim 11, wherein the step of placing the sampling apparatus furtherincludes connecting the second tubular member to a procedural deviceconfigured to be disposed on the patient's nose.
 13. The methodaccording to claim 12, further comprising a connector disposed on thesecond tubular member, the connector being configured to connect to theprocedural device that covers a patient's nose during a medical ordental procedure.
 14. A method, comprising the following steps:providing an oral procedural device configured to connect to a systemicbiomarker sampling device that samples exhaled breath of a patient, theoral procedural device including one of a sampling return line that isat least partially embedded in the oral procedural device, or aconnection component configured to connect to a sampling return line;and positioning the sampling return line in a patient's mouth.
 15. Themethod according to claim 14, wherein the oral procedural deviceincludes a main body, a bite block, and the sampling return line that isat least partially embedded in the oral procedural device and thatextends in the main body and away from the bite block in oppositedirections such that, in use a first portion of the sampling return lineis within the patient's mouth, the first portion having one or morefenestrations therethrough, and a second portion of the sampling returnline extends out of the mouth, the second portion being configured toconnect to a systemic biomarker sampling device, and wherein the step ofpositioning the sampling line further includes positioning the oralprocedural device such that the one or more fenestrations are in thepatient's mouth and are exposed to exhaled breath from the patient. 16.The method according to claim 15, wherein, in use, the fenestrations arepositioned on a back side of the oral procedural device, so as to beexposed to a back portion of a patient's mouth.
 17. The method accordingto claim 14, wherein the oral procedural device is an oral airwayincluding the connection component on an end thereof to attach thesampling return line.
 18. The method according to claim 14, wherein theoral procedural device is a nasal hood having the connection component,wherein the sampling return line is a first sampling return line,wherein a second sampling return line is connected with the firstsampling return line via a joint member, and wherein the method furtherincludes a step of connecting the second sampling return line to thenasal hood by connecting an end of the second sampling return line tothe connection component of the nasal hood.
 19. The method according toclaim 18, further comprising a step of connecting the connectioncomponent to a line-in tube and a line-out tube of the nasal hood suchthat the line-out tube is connected to the second sampling return line.20. The method according to claim 14, wherein the oral procedural deviceis a nasal mask having a connection component, wherein the samplingreturn line is a first sampling return line, wherein a second samplingreturn line is connected with the first sampling return line via a jointmember, and wherein the method further includes a step of connecting thesecond sampling return line to the nasal mask by inserting an end of thesecond sampling return line into a hole on the nasal mask.